Methods and apparatus for overdrive pacing heart tissue using an implantable cardiac stimulation device

ABSTRACT

Techniques are described for overdrive pacing the heart using a pacemaker wherein the overdrive pacing rate only increases when at least two intrinsic beats are detected within a determined search period. In one specific technique, an increase in the pacing rate occurs only if two P-waves are detected within X cardiac cycles. In another specific technique, the overdrive pacing rate is increased only if at least two P-waves are detected within a block of N cardiac cycles. In both techniques, the overdrive pacing rate is decreased if no increase has occurred in the last Z cardiac cycles. By increasing the overdrive pacing rate only in response to detection of at least two P-waves within a determined number of cardiac cycles, an excessively high overdrive pacing rate is avoided. Other techniques are described for adaptively adjusting overdrive pacing parameters so as to achieve a determined target degree of pacing of, for example, 95% paced beats. By adaptively adjusting overdrive parameters to maintain a target degree of pacing, the average overdrive pacing rate is minimized while still maintaining a high number of paced beats, thereby reducing the risk of a tachyarrhythmia occurring within the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.09/471,788, filed Dec. 23, 1999 now U.S. Pat. No. 6,519,493.

FIELD OF THE INVENTION

The invention generally relates to implantable cardiac stimulationdevices such as pacemakers, and in particular, to techniques foroverdrive pacing heart tissue to prevent or terminate dysrhythmia.

BACKGROUND OF THE INVENTION

A dysrhythmia is an abnormal heart beat pattern. One example of adysrhythmia is a bradycardia wherein the heart beats at an abnormallyslow rate or wherein significant pauses occur between consecutive beats.Other examples of dysrhythmias include tachyarrhythmias wherein theheart beats at an abnormally fast rate. With atrial tachycardia, theatria of the heart beat abnormally fast. With ventricular tachycardia,the ventricles of the heart beat abnormally fast. Though oftenunpleasant for the patient, a tachycardia is typically not fatal.However, some tachycardias, particularly ventricular tachycardia, cantrigger ventricular fibrillation wherein the heart beats chaoticallysuch that there is little or no net flow of blood from the heart to thebrain and other organs. Ventricular tachycardia, if not terminated, isfatal. Hence, it is highly desirable to prevent or terminatedysrhythmias, particularly ventricular tachycardias.

One technique for preventing or terminating dysrhythmias is to overdrivepace the heart wherein an implantable cardiac stimulation device, suchas a pacemaker or implantable cardioverter defibrillator (ICD), applieselectrical pacing pulses to the heart at a rate somewhat faster than theintrinsic heart rate of the patient. For bradycardia, the cardiacstimulation device may be programmed to artificially pace the heart at arate of 60 to 80 pulses per minute (ppm) to thereby prevent the heartfrom beating too slow and to eliminate any long pauses between heartbeats. To prevent tachyarrhythmias from occurring, the cardiacstimulation device artificially paces the heart at a rate of at leastfive to ten pulses per minute faster than the intrinsic tachyarrhythmiaheart rate of the patient. In other words, a slight artificialtachycardia is induced and maintained in an effort to prevent an actualtachycardia from arising. If an actual tachycardia occurs, such as asupraventricular tachycardia (SVT) wherein the heart may begin beatingsuddenly at 150 beats per minute or more, the cardiac stimulation devicesenses tachycardia and immediately begins pacing at a rate of at leastfive to ten pulses per minute (ppm) faster than the tachycardia and thenslowly decreases the pacing rate in an effort to slowly reduce the heartrate back to a normal resting rate, thereby terminating the tachycardia.

It is believed that overdrive pacing is effective for at least somepatients for preventing or terminating the onset of an actualtachycardia for the following reasons. A normal, healthy heart beatsonly in response to electrical pulses generated from a portion of theheart referred to as the sinus node. The sinus node pulses are conductedto the various atria and ventricles of the heart via certain, normalconduction pathways. In some patients, however, additional portions ofthe heart also generate electrical pulses referred to as “ectopic”pulses. Each pulse, whether a sinus node pulse or an ectopic pulse has arefractory period subsequent thereto during which time the heart tissueis not responsive to any electrical pulses. A combination of sinuspulses and ectopic pulses can result in a dispersion of the refractoryperiods which, in turn, can trigger a tachycardia. By overdrive pacingthe heart at a uniform rate, the likelihood of the occurrence of ectopicpulses is reduced and the refractory periods within the heart tissue arerendered uniform and periodic. Thus, the dispersion of refractoryperiods is reduced and tachycardias triggered thereby are substantiallyavoided. If a tachycardia nevertheless occurs, overdrive pacing at arate faster than a tachycardia helps to eliminate ectopic pulses andreduce refractory period dispersion, and thereby helps to terminate thetachycardia.

Thus, it is desirable within patients prone to tachyarrhythmias toensure that most beats of the heart are paced beats, as any unpacedbeats may be ectopic beats. A high percentage of paced beats can beachieved simply by establishing a high overdrive pacing rate. However, ahigh overdrive pacing rate has disadvantages as well. For example, ahigh overdrive pacing rate may be unpleasant to the patient,particularly if the artificially-induced heart rate is relatively highin comparison with the heart rate that would otherwise normally occur. Ahigh heart rate may also cause possible damage to the heart or maypossibly trigger more serious dysrhythmias, such as a ventricularfibrillation.

A high overdrive pacing rate may be especially problematic in patientssuffering from heart failure, particularly if the heart failure is dueto an impaired diastolic function. A high overdrive pacing rate mayactually exacerbate heart failure in these patients. Also, a highoverdrive pacing rate may be a problem in patients with coronary arterydisease because increasing the heart rate decreases diastolic time anddecreases perfusion, thus intensifying ischemia. Also, the need to applyoverdrive pacing pulses operates to deplete the implantable cardiacstimulation device's power supply, perhaps requiring frequent surgicalreplacement of the power supply. Typically, the power supply is locatedwithin the implantable cardiac stimulation device and thus this requiressurgical replacement of the cardiac stimulation device.

Problems associated with overdrive pacing are particular severe forcertain aggressive overdrive techniques which trigger an increase in thepacing rate based upon detection of a single intrinsic heart beat. Withsuch techniques, a significant increase in the pacing rate is triggeredby detection of a single intrinsic heart beat so as to promptly respondto the occurrence of a high rate tachycardia, such as an SVT. As aresult, even in circumstances where a high rate tachycardia has notoccurred, the detection of a single intrinsic heart beat can cause asignificant increase in the overdrive pacing rate, which may be reducedonly gradually. If a second intrinsic heart beat is detected before theoverdrive pacing rate has been gradually lowered to a standard overdrivepacing rate, a still further increase in the pacing rate occurs. As canbe appreciated, the foregoing can cause the overdrive pacing rate toincrease significantly, perhaps to 150 ppm or more, even though a highrate tachycardia has not occurred.

Hence, it would be desirable to provide techniques for overdrive pacingwhich reduce the average overdrive pacing rate, yet still attain asufficiently high rate to significantly reduce the likelihood of adysrhythmia within the patient or to terminate a dysrhythmia if onenevertheless occurs. In particular, it would be highly desirable toprovide overdrive pacing techniques which permit a certain percentage ofpaced beats (such as 90% or 95%) to be sustained by the cardiacstimulation device so as to enable the overdrive pacing rate to beminimized while still ensuring that most beats of the heart are pacedbeats. It is to these ends that aspects of the present invention areprimarily directed.

SUMMARY

In accordance with a first embodiment, a method is provided foroverdrive pacing a heart using an implantable cardiac stimulation devicewherein the overdrive pacing pulses are delivered to the heart based onone or more overdrive pacing parameters. A degree of pacing resultingfrom the overdrive pacing pulses is then determined, and one or more ofthe overdrive pacing parameters are adjusted based on the degree ofpacing.

In accordance with another embodiment, a system is provided forcontrolling overdrive pacing of a heart. The system includes acontroller that is operative to determine an overdrive pacing rate, anda pulse generator that is controlled by the controller to generateoverdrive pacing pulses at the overdrive pacing rate for delivery to theheart. A determination unit is provided to determine a degree of pacingresulting from the overdrive pacing pulses. The controller is coupled tothe determination unit and is operative to vary the overdrive pacingrate based on the degree of pacing.

Other aspects, features, and advantages of the invention will beapparent from the detailed description which follows in the combinationwith the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram illustrating a pacemaker, internallyconfigured in accordance with the invention, and connected to apatient's heart.

FIG. 2 is a timing diagram illustrating paced beats and unpaced beatswithin the heart of FIG. 1.

FIG. 3 is a flow chart illustrating an overdrive pacing method whereinan overdrive pacing rate is increased only if at least two intrinsicevents are detected within X cardiac cycles of one another.

FIG. 4 is a flow chart illustrating an overdrive pacing method whereinan overdrive pacing rate is increased only if at least two intrinsicheart beats are detected within a block of N consecutive cardiac cycles.

FIG. 5 is a flow chart illustrating a method for adaptively varyingprogrammable values defining overdrive pacing characteristics so as tomaintain a target degree of pacing.

FIG. 6 is a flow chart of the method of FIG. 5 configured for adaptivelyvarying an overdrive pacing rate.

FIG. 7 is a flow chart illustrating a method for adaptively modifyingthe automatic pacing cycle length adjustment to maintain a target degreeof pacing.

DETAILED DESCRIPTION

With reference to the figures, preferred and exemplary embodiments ofthe invention are described. Briefly, the invention relates totechniques for controlling overdrive pacing so as to achieve andmaintain a target degree of pacing. The techniques will first bedescribed with reference to FIGS. 1–4 wherein an overdrive pacing rateis increased only in response to detection of at least two intrinsicheart beats within some predetermined number of cardiac cycles. Then,techniques of the invention will be described with reference to FIGS.5–7 wherein programmable values specifying overdrive pacingcharacteristics are adaptively varied so as to maintain a targetpercentage of paced beats.

FIG. 1 illustrates an implantable cardiac stimulating device 10 (such asa pacemaker) coupled to a patient's heart 12 by way of a ventricularlead 14 and an atrial lead 16. Ventricular lead 14 includes an electrode18 positioned in the right ventricle 20 of the heart 12 and atrial lead16 includes an electrode 22 positioned in the right atrium 24 of theheart 12 (preferably using a screw-in active fixation lead). Variousinternal components of the pacemaker operate to sense the electricalactivity of the heart 12, such as the presence of P-waves and R-waves,using electrodes 18 and 22 and to selectively stimulate the heart inresponse to events sensed within the heart 12 by conducting electricalstimulation pulses to the heart 12 using the electrodes 18 and 22. Amongother functions, the pacemaker operates to overdrive pace the heart 12in accordance with techniques to be described below in an effort toprevent the occurrence of a tachycardia or, if a tachycardianevertheless occurs, to terminate the tachycardia.

FIG. 2 illustrates a sequence of pacing pulses 102 administered by thecardiac stimulation device 10 of FIG. 1. Each electrical pacing pulsetriggers an evoked response 104 representative of an artificiallyinduced heart beat. Pulses 102 are administered at a constant pacingrate and, therefore, are separated by a constant pacing cycle length.FIG. 2 also illustrates a single unpaced beat 106 not preceded by apacing pulse 102. Unpaced beat 106 may be, for example, an ectopic beatcause by a naturally occurring electrical signal generated within theheart from a location other than the sinus node from which normal sinusrhythm heart beats are naturally generated. As discussed above, ectopicbeats have been found to sometimes trigger tachyarrhythmias and hence itis desirable to minimize the number of ectopic beats. Accordingly, thecardiac stimulation device 10 of FIG. 1 performs an overdrive pacingalgorithm intended to generate overdrive pacing pulses 102 at asufficiently high rate to minimize the number of unpaced beats 106without causing an unnecessarily high heart rate. To this end, thecardiac stimulation device 10 determines the actual degree of pacingresulting from the overdrive pacing pulses and adaptively modifies theoverdrive pacing rate to maintain the actual degree of pacing at about atarget degree of pacing wherein about 95% of the total beats are pacedbeats.

FIG. 3 illustrates a technique for overdrive pacing a heart wherein anoverdrive pacing rate is increased only in response to the detection ofat least two intrinsic P-waves occurring within X cardiac cycles of oneanother wherein X is, typically, between eight and forty cardiac cycles.Briefly, the technique is summarized as follows:

-   -   1. Identify a P-wave.    -   2. If another P-wave occurs within X cardiac cycles, increase        the pacing rate by Y bpm.        -   a) X is preferably programmable from about 8 to 40 cardiac            cycles.        -   b) Y is the programmable rate increase and is preferably            programmable to 5, 10, 15, 20 or 25 ppm.    -   3. If Z cardiac cycles occur without a pacing rate increase,        then decrease the pacing rate by W ppm.        -   a) Z is the dwell time before the pacing rate is decreased            and is preferably programmable from 8 to 40 cardiac cycles.        -   b) W is preferably programmable at 1, 2, 3, 4, or 5            ppm/cardiac cycle.

Additionally, the cardiac stimulation device 10 periodically suspendspacing to permit detection of three consecutive P-waves. At that time,the sinus rate is computed based upon the detected P-waves and theoverdrive pacing rate is reset to be equal to the sinus rate.

This technique will now be explained more fully with reference to FIG.3. Initially, at step 200, the intrinsic sinus rate is detected bydetecting three consecutive P-waves. At step 204, a current overdrivepacing rate is set to be equal to the detected sinus rate. At step 206,the cardiac stimulation device 10 begins to count the number of pacedcycles (I_(RESET)) since the overdrive pacing rate was set based uponthe intrinsic sinus rate. This count of paced cycles is eventuallycompared with a rate recalibration value in step 218 (described below)and if it exceeds the recalibration value, step 200 is repeated todetect a new intrinsic sinus rate for resetting of the overdrive pacingrate.

At step 208, the atria of the heart is paced at the current overdrivepacing rate. At step 210, the number of cycles (I_(CYCLES)) since pacingbegan at the current rate is counted. Note that, I_(RESET) andI_(CYCLES) are initially equal to one another. However, as will bedescribed, the values typically diverge from one another with furtherexecution of the method steps. I_(CYCLES) is eventually compared againsta rate recovery value Z at step 214 (described below) and if I_(CYCLES)exceeds Z, the overdrive pacing rate is decreased.

At step 212, the cardiac stimulation device 10 detects any intrinsicP-waves. If a P-wave is not detected, processing proceeds to step 214wherein the count of paced cycles since pacing began at the current rate(I_(CYCLES)) is compared with the rate recovery value (Z). If I_(CYCLES)exceeds Z, then step 216 is performed wherein the current overdrivepacing rate is decreased by a pacing decrement amount W, preferablypreset to 1, 2, 3, 4, or 5 ppm. Processing then returns to step 206 forcontinued pacing at the newly reduced overdrive pacing rate. Thus, if atleast I_(CYCLES) of pacing occurs before detection of a single intrinsicP-wave, the current overdrive pacing rate is reduced to provide for arate of recovery. If, at step 214, I_(CYCLES) does not exceed Z, thenstep 218 is performed wherein the cardiac stimulation device 10determines whether the count of paced cycles since the current rate wasoriginally set (I_(RESET)) exceeds a rate recalibration value(N_(RECALIBRATION)). If I_(RESET) exceeds N_(RECALIBRATION), then step200 is again executed wherein a new sinus rate is detected and theoverdrive pacing rate is reset to the new sinus rate. This ensures thatthe overdrive pacing rate does not remain significantly different fromthe sinus rate for any extended period of time. If, at step 218,I_(RESET) does not exceed N_(RECALIBRATION), then processing returns tostep 206 for additional pacing at the current overdrive pacing rate.

What has been described thus far with respect to FIG. 3 arecircumstances wherein no intrinsic P-waves are detected. Steps performedin response to the detection of P-waves will now be described. Morespecifically, if at step 212 an intrinsic P-wave is detected, then step220 is performed wherein a determination is made as to whether a counthas already begun of the number of overdrive pacing cycles sincedetection of the last detected P-wave. During the first execution ofstep 220 following detection of the first P-wave, the count has not yetbegun and hence processing continues to step 222 wherein the cardiacstimulation device 10 begins to count the number of overdrive pacingcycles since the last detected P-wave (I_(P-WAVE)) Processing thenreturns to step 206 for additional pacing at the current overdrivepacing rate while incrementing I_(P-WAVE) (along with I_(RESET) andI_(CYCLES)) with each additional pacing cycle.

If another P-wave is detected at step 212, then execution proceedsthrough step 220 to step 224 wherein I_(P-WAVE) is compared with apacing cycle increment value (X). If I_(P-WAVE) is less than X,indicating that the last two detected intrinsic P-waves are within Xcardiac cycles of one another, then step 226 is performed wherein thecurrent overdrive pacing rate is increased by a predetermined pacingincrement amount (Y) set to, for example, 5, 10, 15, 20, or 25 ppm.Thereafter, pacing continues from step 206 at the new higher overdrivepacing rate. If, however, at step 224, I_(P-WAVE) was found to begreater than X, meaning that the last two detected intrinsic P-waveswere more than X cycles apart, then the overdrive pacing rate is notimmediately increased. Instead, processing proceeds to step 222 whereinI_(P-WAVE) is reset to begin a new count of the number of overdrivepacing cycles since the most recently detected P-wave.

Thus, FIG. 3 is a flow chart illustrating one technique for implementingan overdrive pacing algorithm which, among other features, (1) increasesan overdrive pacing rate if two P-waves are detected within X cardiaccycles of one another, (2) decreases the overdrive pacing rate if a rateincrease does not occur within at least Z cardiac cycles, and (3) resetsthe overdrive pacing rate to be equal to a detected sinus rate everyN_(RECALIBRATION) number of cardiac cycles regardless of the extent towhich the overdrive pacing rate is modified during the interim.

FIG. 4 illustrates a method for controlling overdrive pacing wherein anoverdrive pacing rate is increased only if at least two intrinsic atrialbeats are detected within a block of N consecutive cardiac cycles. Thetechnique of FIG. 4 is summarized as follows:

-   -   1. At the conclusion of a block of N cardiac cycles, the cardiac        stimulation device determines if there is more than one P-wave        in the block of cardiac cycles. If there is more than one        P-wave, the pacing rate is increased by Y ppm.        -   a) Y is a programmable rate increment and is preferably            programmable to 5, 10, 15, 20 or 25 ppm.    -   2. If Z cardiac cycles occur without increasing the pacing rate,        then the pacing rate is decreased by W ppm.        -   a) Z is the dwell time before the pacing rate is decreased            and is preferably programmable from 8 to 40 cardiac cycles.        -   b) W is preferably programmable at 1, 2, 3, 4, or 5 ppm.

Additionally, the cardiac stimulation device 10 periodically suspendspacing to detect the intrinsic atrial rate and compare the intrinsicatrial rate with a current overdrive pacing rate. If the differencebetween the atrial rate and the overdrive pacing rate exceeds apredetermined threshold (N_(THRESHOLD)), then the overdrive pacing rateis reset to the detected atrial rate. Otherwise, overdrive pacingcontinues at the current pacing rate.

The technique will now be described in greater detail with reference toFIG. 4. Certain steps of FIG. 4 are similar to those of FIG. 3 and,accordingly, will not be re-described in detail. Initially, at steps 300and 302, the cardiac stimulation device 10 detects the current intrinsicatrial rate and sets a current overdrive pacing rate based on thedetected atrial rate. Initially, the overdrive pacing rate is set to beequal to the detected atrial rate. During subsequent iterations of steps300 and 302, the overdrive pacing rate is set to the atrial rate only ifthe atrial rate minus the current overdrive pacing rate exceedsN_(THRESHOLD).

At step 304, the cardiac stimulation device begins to count all pacedcycles (I_(RESET)) since the overdrive pacing rate was set at step 302.At step 305, the cardiac stimulation device 10 paces the atria at thecurrent overdrive pacing rate while detecting any intrinsic P-waves. Atstep 306, all paced cycles since pacing began at the current rate aredetected and counted (I_(CYCLES)). At step 308, the cardiac stimulationdevice 10 also counts every group of N consecutive paced cycles (I_(N))wherein N is, for example, ten. Initially, the counts initiated at steps302, 306 and 308 will be the same. As will be seen, however, thesecounts may diverge from one another with further processing of themethod steps.

At step 310, the cardiac stimulation device 10 determines whether Npacing cycles have elapsed by examining I_(N). If I_(N) equals N, thenstep 312 is performed wherein the cardiac stimulation device 10determines whether at least two intrinsic P-waves have been detectedwithin the group of N paced cycles. If so, the current overdrive pacingrate is increased at step 314 by an amount Y wherein Y is equal to, forexample, 5, 10, 15, 20 or 25 ppm. Thereafter, processing returns to step304 for additional atrial pacing at the new overdrive pacing rate. If,at step 312, at least two intrinsic P-waves were not detected within thegroup of N paced cycles, then step 316 is performed wherein the count ofN paced cycles (I_(N)) is reset such that the next set of N consecutivepaced cycles may be counted. In this manner, the overdrive pacing rateis increased if, and only if, at least two P-waves are detected within agroup of N consecutive cardiac cycles.

If, at step 310, N paced cycles have not yet elapsed (i.e., the countI_(N) is less than N), then step 318 is performed wherein the cardiacstimulation device 10 determines whether the count of paced cycles sincepacing began at the current rate (I_(PACED)) exceeds a rate recoveryvalue (Z). If so, then at step 320, the overdrive pacing rate isdecreased by a pacing decrement amount W, wherein W is preset to, forexample, 1, 2, 3, 4 or 5 ppm. Hence, if the overdrive pacing rate hasnot been increased as a result of the detection of at least two P-waveswithin a block of N cycles, then the overdrive pacing rate is decreasedto provide rate recovery.

If, at step 318, I_(CYCLES) does not exceed Z, then step 322 isperformed wherein the cardiac stimulation device 10 determines whetherthe count of paced cycles since the current rate originally set(I_(RESET)) in step 302 exceeds a rate calibration valueN_(RECALIBRATION). If so, then steps 300 and 302 are repeated whereinoverdrive pacing is suspended to permit detection of the intrinsicatrial rate and the overdrive pacing rate is then set based upon theintrinsic atrial rate. As noted above, within step 302, a determinationis made as to whether the difference between the intrinsic atrial rateand the overdrive pacing rate exceeds a threshold N_(THRESHOLD) and, ifnot, the overdrive pacing rate is not reset to be equal to the atrialrate. If, at step 322, I_(RESET) does not exceed N_(RECALIBRATION), thenprocessing merely returns to step 304 for additional pacing at thecurrent overdrive pacing rate.

Thus, FIG. 4 illustrates an overdrive pacing technique wherein, amongother features, (1) an overdrive pacing rate is increased only if atleast two P-waves are detected within a block of N consecutive cardiaccycles, (2) the overdrive pacing rate is decreased if the overdrivepacing rate is not increased within Z consecutive cardiac cycles, and(3) the overdrive pacing rate is periodically reset to an intrinsicatrial rate if the difference between the atrial rate and the currentoverdrive pacing rate exceeds a predetermined threshold. By increasingthe overdrive pacing rate only in response to the detection of at leasttwo P-waves within a block of N consecutive cardiac cycles, excessivelyaggressive overdrive pacing rate increases are avoided. Additionally,with appropriate selection of N, a minimum percentage of paced cyclescan be achieved on the average. For example, by setting N equal to ten,the average percentage of paced cycles will be maintained at about 90%.If more than ten percent of the cardiac cycles are intrinsic cycles,then the overdrive pacing rate is increased. Otherwise, the overdrivepacing rate is periodically decreased. Hence, an average of about 90% issustained.

With reference to FIG. 5, techniques for adaptively varying overdrivepacing characteristics are summarized. Initially, at step 400, aparticular overdrive pacing technique or algorithm is selected by thecardiac stimulation device. Then, at step 401, programmable values,i.e., control values, are input from a memory 402 for control of theoperation of the algorithm. (If the implantable cardiac stimulationdevice 10 is capable of performing only a single overdrive pacingtechnique, step 400 is not necessary.) Depending upon the overdrivepacing technique, the programmable values may be representative of: anoverdrive pacing rate, an overdrive pacing margin, a pacing cyclelength, a number of pacing pulses prior to pacing cycle length extension(Z), an amount of time prior to pacing cycle length extension, a numberof unpaced beats prior to pacing cycle length extension, a rateincrement magnitude (Y), a rate decrement magnitude (W), a search windowduration (X), a pacemaker base rate, and a sensor modulated base rate.

At step 403, the cardiac stimulation device 10 applies overdrive pacingpulses to the heart in accordance with the requisite programmablevalues. While overdrive pacing is performed, the cardiac stimulationdevice 10 performs steps 404–412 to adjust the programmable values so asto reduce any difference between an actual degree of pacing and a targetdegree of pacing. More specifically, at step 404, the cardiacstimulation device 10 determines the actual degree of pacing resultingfrom the pacing pulses. The actual degree of pacing may be representedby a percentage of paced beats (determined as a function of time or as afunction of cardiac cycles) or by any other appropriate factor. At step406, a target degree of pacing is input from a memory 408 and, at step410, the cardiac stimulation device 10 compares the actual degree ofpacing with the target degree of pacing. At step 412, the cardiacstimulation device 10 adjusts the values used from memory 402 so as toreduce any difference between the actual degree of pacing and the targetdegree of pacing. The specific adjustment depends upon a particularprogrammable value being adjusted. In some cases, a value may need to beincreased so as to cause a decrease in the degree of pacing. In othercases, a value may need to be decreased so as to cause a decrease in thedegree of pacing. The direction of the adjustment and the magnitude ofthe adjustment are set so as to achieve a negative feedback loop whichconverges the actual degree of pacing to the target degree of pacing. Tothis end, routine experiments are performed to determine optimal valuesfor adjusting the various parameters to achieve the desired feedbackloop and to eliminate adjustment values, if any, which may result in apositive feedback loop causing the actual degree of pacing to deviatefrom the target degree of pacing, rather than to converge to the targetdegree of pacing. The resulting adjustment in the values may be linearor non-linear, depending upon the particular programmable values anddepending upon the amount of difference, if any, between the actualdegree of pacing and the target degree of pacing. As can be appreciated,a wide range of possible adjustments can be employed consistent with theinvention depending upon the characteristics of the overdrive pacingtechnique being implemented. In many cases, two or more programmablevalues are adjusted simultaneously. For example, both the overdrivepacing margin and the number of pacing pulses prior to a pacing cyclelength extension may be adaptively adjusted.

A first specific example of the technique of FIG. 5 will now bedescribed with reference to FIG. 6. In this specific example, thecardiac stimulation device 10 operates to maintain the overdrive pacingrate at a rate equal to the intrinsic rate plus a programmable ratemargin. The rate margin is adaptively varied so as to maintain a targetdegree of pacing. Initially, at step 500, the cardiac stimulation device10 inputs an initial overdrive pacing margin from a memory unit 502. Themargin may be, for example, five beats per minute (bpm)—indicating thatthe heart is to be paced at a rate equal to the intrinsic heart rateplus five bpm. At step 504, the cardiac stimulation device 10periodically determines the intrinsic heart rate and administersoverdrive pacing pulses to the heart at a rate equal to the intrinsicrate plus the overdrive pacing margin. For example, if the intrinsicrate is found to be 60 bpm, the cardiac stimulation device 10 overdrivepaces the heart at a rate of 65 ppm. If the intrinsic rate is found toincrease to 80 bpm, then the overdrive pacing rate automaticallyincreases to 85 ppm. In this manner, the cardiac stimulation device 10seeks to maintain the overdrive pacing rate at a rate slightly higherthan the intrinsic rate at all times.

A determination of the intrinsic rate at step 504 may be performed, forexample, by periodically deactivating overdrive pacing therebypermitting detection of intrinsic beats from which the intrinsic heartrate is determined. In this regard, an estimate of the intrinsic heartrate may be calculated based upon the duration of time between thedetected intrinsic beats. The greater the number of intrinsic beats thatare detected, the more precise the determination of the intrinsic heartrate.

Step 506 is periodically performed wherein the cardiac stimulationdevice counts the number of paced beats and the number of unpaced beatsuntil a predetermined period of time, such as 60 seconds, has elapsed.Alternatively, the cardiac stimulation device 10 counts the beats untila predetermined number of total beats, such as 100 beats, have beencounted. The cardiac stimulation device 10 then calculates a percentageof the number of paced beats out of a total number of beats. In theexample of FIG. 2, with nine paced beats and one unpaced beat, thepercentage of paced beats is about 90%. At step 508, the cardiacstimulation device 10 inputs a target degree of pacing from a memoryunit 510. The target of pacing may be, for example, 95% paced beats. Atstep 512, the cardiac stimulation device 10 determines whether theactual percentage of paced beats determined at step 506 is greater thanthe target percentage of paced beats input at step 508. If so, then step514 is performed wherein the cardiac stimulation device 10 automaticallydecreases the overdrive pacing margin by a predetermined amount, such asone ppm. If not, then step 516 is performed wherein the cardiacstimulation device 10 automatically increases the overdrive pacingmargin by the predetermined amount.

Thereafter, step 504 is performed using the adjusted overdrive pacingmargin. Hence overdrive pacing may now occur at a rate of six ppm abovethe intrinsic rate or perhaps only at a rate of four ppm above theintrinsic rate. With repeated iterations of steps 504–516, the degree ofoverdrive pacing is thereby periodically, adaptively adjusted so as tomaintain the actual percentage of paced beats at an amount about equalto the target degree of pacing, e.g., at about 95%. Hence, if theinitial overdrive pacing adjustment factor was too high such thatsubstantially 100% of heart beats were paced beats, the overdrive pacingadjustment factor is decreased somewhat to permit occasional detectionof an unpaced beat. This helps ensure that the overdrive pacing rate isnot so high so as to possibly adversely affect the health of thepatient. Also, avoidance of an unnecessarily high overdrive pacing ratehelps preserve battery longevity. Moreover, in embodiments wherein thecardiac stimulation device relies upon detection of an occasionalintrinsic beat so as to determine the intrinsic heart rate, a reductionof the overdrive pacing rate helps ensure that intrinsic beats areoccasionally detected. On the other hand, if the actual degree ofoverdrive pacing was found to be significantly less than 95%, then theoverdrive pacing rate is increased so as to prevent too many intrinsicbeats from occurring which might trigger a tachyarrhythmia.

Although not specifically shown in FIG. 6, if, at step 512, the actualpercentage of pacing is found to be exactly equal to the target degreeof pacing, then the cardiac stimulation device 10 may be configured tonot adjust the overdrive pacing adjustment factor either up or down.Also, the predetermined amount by which the overdrive pacing margin isincreased may differ from that in which it is decreased. Also, thepredetermined amounts may vary depending upon the current overdrivepacing rate or upon the current overdrive pacing adjustment factor. Forexample, if the overdrive pacing margin is currently set to 20 ppm, thefactor may be increased or decreased by a greater amount than if theoverdrive pacing margin was currently set to two or three ppm. Likewise,if the current overdrive pacing rate (i.e., the sum of the currentintrinsic heart rate and the current overdrive pacing margin) isparticularly high, then the predetermined amounts may also be relativelyhigh. Also, note that the overdrive pacing margin may, at times, benegative. As can be appreciated, a wide range of alternatives may beprovided consistent with the principles of the invention.

Another specific example of the technique of FIG. 5 will now bedescribed with reference to FIG. 7. In this specific example, thecardiac stimulation device 10 performs a dynamic atrial overdrivetechnique wherein detection of a single P-wave triggers an immediate,significant increase in the overdrive pacing rate and wherein, after anincrease, the pacing cycle length is periodically extended to graduallyreduce the overdrive pacing rate. More specifically, the dynamic atrialoverdrive technique operates as follows. The cardiac stimulation device10 monitors the atria of the heart and detects P-waves and, in responseto detection of a single P-wave, increases the overdrive pacing rate bya programmable increment value which depends upon whether the currentoverdrive base rate is within: 1) a lower rate overdrive (LRO) regime ofbetween 25 and 59 ppm, 2) a middle rate overdrive regime (MRO) ofbetween 60 and 149 ppm, or 3) an upper rate overdrive (URO) of between150 and 185 ppm.

Within the LRO regime, the cardiac stimulation device 10 increases theoverdrive pacing rate with each sensed P-wave by an LRO incrementprogrammable value, e.g., 5, 10, 15, 20 and 25 ppm. Within the UROregime, the cardiac stimulation device 10 increases the overdrive pacingrate with each sensed P-wave by a URO increment programmable value,e.g., 5 or 10 ppm. (Typically, the LRO increment value is programmed toa high value, such as 25 ppm, whereas the URO increment is programmed toa low value such as 5 ppm.) Within the MRO regime, the cardiacstimulation device 10 increases the overdrive pacing rate with eachsensed P-wave by an MRO increment which is a blended value between theLRO increment and the URO increment. The MRO increment is equal to theLRO increment when the base rate is 60 ppm. The MRO increment variesgradually when the base rate is in the range of 60 ppm to 150 ppm untilthe increment is equal to the URO increment when the base rate is equalto 150 ppm.

The cardiac stimulation device 10 also exploits a dynamic rate recoverytechnique wherein the overdrive base rate is decreased if apredetermined number of pacing cycles occur without any detectedP-waves. The predetermined number of cycles and the amount of thedecrease are both programmable. The amount of the decrease variesdepending upon whether the base overdrive pacing rate is within one oftwo regimes.

The specific operation of the cardiac stimulation device 10 within thevarious regimes is described with reference to the following examples.

As an example of operation within the LRO regime, if the currentoverdrive pacing rate is 45 ppm, the LRO increment value is 5 ppm, and aP-wave is sensed, the current overdrive pacing rate is immediatelyincreased to 50 ppm. If the P-wave arises from intrinsic atrial activityoccurring at a rate of 53 bpm, then a second P-wave will be detectedbefore a paced beat can be generated (because the overdrive base rate isstill below the intrinsic rate). Hence, another P-wave is detected andthe overdrive pacing rate increases to 55 ppm.

As another example of operation within the LRO regime, if the currentoverdrive pacing rate is 55 ppm, the LRO increment is 25 ppm, the UROincrement is 5 ppm, and the patient experiences an SVT at 160 bpm, thenthe overdrive pacing rate increases by 25 ppm with each sensed atrialbeat until the overdrive pacing rate exceeds 60 ppm. Then, any furtherincrements begin at slightly less than the LRO increment of 25 ppm andare gradually reduced to the URO increment of 5 ppm when the overdrivepacing rate exceeds 150 ppm.

To provide rate recovery, the cardiac stimulation device 10 counts thenumber of pacing pulses delivered at a current overdrive pacing rateand, if the number of cycles exceeds a threshold value N_(MAX), thecardiac stimulation device 10 decreases the overdrive pacing rate byincreasing a pacing cycle length (CL) equal to the amount of timebetween individual pacing pulses. N_(MAX) is preferably programmablewithin a range of 1 to 32 cycles. Thus, if N_(MAX) is programmed to 10cycles and the overdrive pacing rate has remained constant for 10cycles, then the CL is increased by a programmable rate recovery value.In this manner, so long as no intrinsic activity is detected, theoverdrive pacing rate gradually decreases. Whenever intrinsic atrialactivity is sensed, the counter associated with N_(MAX) is reset and, inaccordance with the techniques already described, the overdrive pacingrate is incremented. Exemplary programmable CL increment values are:

Milliseconds/Cycle  6;13  6;19 13;19 19;25

As noted, an increase in the pacing cycle length causes a correspondingdecrease in the overdrive pacing rate. In the foregoing, the first valuerepresents the increase in CL in milliseconds per cycle to be used ifthe current base rate is over 100 ppm. The second value represents theincrease in CL in milliseconds per cycle to be used if the current baserate is 100 ppm or less. Thus, two base CL increment regimes are used.

In a specific rate recovery example, if the current overdrive pacingrate is 102 ppm, the intrinsic atrial rate is 90 ppm, and the dynamicrate recovery values are programmed to 6;19 milliseconds/cycle, then thepacing cycle length decreases after every N_(MAX) as follows:

-   -   (1) 595 milliseconds (101 ppm)    -   (2) 601 milliseconds (100 ppm)    -   (3) 620 milliseconds (97 ppm)    -   (4) 639 milliseconds (94 ppm)    -   (5) 658 milliseconds (91 ppm)

Thus, the cardiac stimulation device 10 employs a dynamic atrialoverdrive technique which increases an overdrive base rate very promptlyin response to detection of intrinsic atrial activity (i.e., P-waves)and provides a rate recovery technique for reducing the overdrive pacingrate when overdrive pacing is no longer needed. The degree of incrementor decrement to the overdrive pacing base rate depends, as describedabove, upon the current base rate regime. Additional variations to theoverdrive pacing rate may be based upon detection of pre-atrialcontractions (PAC) or other intrinsic events.

In the technique of FIG. 7, N_(MAX) is adaptively varied to maintain atarget degree of pacing. Initially, at step 600, the cardiac stimulationdevice 10 inputs both an initial pacing cycle length (CL) and N_(MAX)from a memory unit 602. CL may be, for example, one second(corresponding to an overdrive pacing rate of 60 ppm) and N_(MAX) maybe, for example, initially set to ten.

At step 604, the cardiac stimulation device 10 repeatedly administersoverdrive pacing pulses to the heart in accordance with the dynamicatrial overdrive algorithm described above wherein the CL isautomatically extended every N_(MAX) pulses to allow occasionaldetection of intrinsic heart beats or other intrinsic activity. Whilestep 604 is performed, the cardiac stimulation device 10 additionallyperforms steps 606–616 as follows. The cardiac stimulation device countsthe number of paced beats and unpaced beats for either a predeterminedperiod of time or a predetermined number of pulses then calculates thepercentage of paced beats at step 606. A target degree of pacing isinput at step 608 from a memory 610 and, at step 612, the cardiacstimulation device 10 determines whether the actual percentage of pacingis greater than the target percentage of pacing. If so, then N_(MAX) isdecreased by a predetermined amount, such as one cycle, at step 614. Ifnot, then N_(MAX) is increased by a predetermined amount, such as onecycle, at step 616. Thereafter, the overdrive pacing performed by thecardiac stimulation device 10 during step 604 is performed using theadjusted value for N_(MAX). With repeated iterations of steps 604–616,the actual degree of pacing is maintained substantially at or near thetarget degree of pacing so as to prevent excessive overdrive pacingwhile still minimizing the number of non-paced beats. In this regard,N_(MAX) is decreased when the actual percentage of pacing is greaterthan the target percentage of pacing so as to permit a more promptdetection of an intrinsic pulse from which a new intrinsic heart rate isdetermined. By permitting a more prompt detection of a next intrinsicbeat, the overdrive pacing rate can thereby be adjusted in accordancewith the dynamic atrial overdrive algorithm to more closely match theintrinsic rate. In contrast, by increasing N_(MAX) if the actualpercentage of pacing is found to be less than 95%, a greater amount oftime elapses prior to detection of a next intrinsic pulse, therebydelaying readjustment of the overdrive pacing rate. This may result in agenerally higher overdrive pacing rate. In any case, regardless ofwhether the adjustments to N_(MAX) result in an increase or decrease inthe overall average overdrive pacing rate, the adjustments to N_(MAX)will typically operate to maintain the percentage of paced beats atabout the target percentage and the advantages set forth above areachieved.

In another specific example of the technique of FIG. 5, the implantablecardiac stimulation device 10 employs a technique for modulating thebase rate of the cardiac stimulation device 10 based upon circadianrhythms of the patient. The technique for modulating the base rate isdescribed in U.S. Pat. No. 5,476,483 to Bornzin et al. which isincorporated by reference herein. Briefly, in accordance with thetechnique of the Bornzin et al. patent, the base rate associated with atransfer function of a rate-responsive cardiac pacemaker is modulated.Activity sensor measurements are used to derive activity variancemeasurements, which in turn are used to modulate the base pacing rate.In one embodiment, a histogram is used to store activity variancemeasurements collected over a period of about one week. A histogram isused to derive an activity variance threshold, which is compared tocurrent activity variance measurements to determine if the patient isasleep. If the patient is deemed to be asleep, the pacing rate is set toa rate that comfortably meets the low metabolic demands of the patientduring sleep. In alternative embodiments, the activity variancemeasurements are applied to a base rate slope to modulate the basepacing rate.

Thus, the base rate can be modulated and as such, the percentage of timethat underlying, intrinsic P-waves are detectable during a search periodcan be adjusted by adaptively adjusting the base rate in accordance withthe adaptive techniques described above. With proper selection ofappropriate adaptive adjustment values (when the cardiac stimulationdevice extends an atrial escape interval to permit detection of anunderlying, intrinsic P-wave), the adjusted base rate will limit theextension of the escape interval so that the base rate is in fact higherthan the underlying atrial rate. Accordingly, there will be few, if any,emerging P-waves. More specifically, parameters sleep rate and BPR_slopewithin Equation 9 of the Bornzin et al. patent are adaptively adjustedso as to achieve a target degree of pacing. Increasing sleep rate andBPR_slope has the effect of increasing the base rate and thus increasingthe percentage of atrial pacing.

What has been described are various techniques for overdrive pacingincluding techniques for adaptively adjusting overdrive pacingprogrammable values so as to maintain a desired or target degree ofoverdrive pacing, or to maintain any other desirable characteristic ofthe overdrive pacing. The overdrive pacing techniques have beendescribed primarily with reference to flow charts illustrating stepsperformed by components of an implantable cardiac stimulating device.Each method step of the flow charts additionally represents a functionalcomponent for performing the method step. The functional component maycomprise individual hardware devices or may comprise softwarecomponents. In some cases a single functional component will perform twoor more method steps. In other cases two or more functional componentsin combination will perform a single method step. In general, thetechniques described herein may be implemented using any appropriatetechnology such as hardware, software, firmware, or the like.

The examples described herein are merely illustrative of the inventionand should not be construed as limiting the scope of the invention.Accordingly, the scope of the present invention is defined by thefollowing claims.

1. A method for controlling overdrive pacing of a heart, the methodcomprising: applying overdrive pacing pulses to the heart based on oneor more overdrive pacing parameters; determining a degree of pacingresulting from the overdrive pacing pulses; and varying one or more ofthe overdrive pacing parameters based on the degree of pacing.
 2. Themethod of claim 1 wherein applying overdrive pacing pulses furthercomprises selecting at least one of the following parameters: anoverdrive pacing rate, an overdrive pacing cycle length, a number ofpacing pulses to be administered prior to a pacing cycle lengthextension, an amount of time prior to a pacing cycle length extension, anumber of unpaced beats detected prior to a pacing cycle lengthextension, a magnitude of rate increment, a magnitude of rate decrement,a search window duration, a pacemaker base rate, and a sensor modulatedbase rate.
 3. The method of claim 1 wherein determining the degree ofpacing comprises: determining a number of paced beats occurring during aperiod of overdrive pacing; determining a number of unpaced beatsoccurring during the period of overdrive pacing; and calculating thedegree of pacing based on a comparison of the number of paced beats andthe number of unpaced beats occurring during the period of overdrivepacing.
 4. The method of claim 3 wherein calculating the degree ofpacing based on the comparison of the number of paced beats and thenumber of unpaced beats comprises determining a percentage of pacedbeats out of a total number of paced beats and unpaced beats.
 5. Themethod of claim 1 wherein varying one or more of the overdrive pacingparameters comprises: inputting a target value representative of atarget degree of pacing; comparing the degree of pacing with the targetdegree of pacing; and adjusting one or more of the overdrive pacingparameters to reduce a difference, if any, between the degree of pacingand the target degree of pacing.
 6. The method of claim 5 wherein: thecontrol values representative of the overdrive pacing characteristicsinclude a pacing cycle length and a number of pacing pulses administeredprior to a pacing cycle length extension; and wherein applying overdrivepacing pulses further comprises: counting a number of pacing pulses; andincreasing the pacing cycle length when a count of the number of pacingpulses exceeds the parameter representative of the number of pacingpulses to be administered prior to a pacing cycle length extension. 7.The method of claim 6 wherein varying the selected rate comprises:increasing the number of pacing pulses to be administered prior to apacing cycle length extension if the degree of pacing is less than thetarget degree of pacing; and decreasing the number of pacing pulses tobe administered prior to a pacing cycle length extension if the degreeof pacing is more than the target degree of pacing.
 8. A systemcomprising: means for generating overdrive pacing pulses at an overdrivepacing rate for delivery to at least one heart chamber; means fordetermining a degree of pacing resulting from the overdrive pacingpulses; and means for varying the overdrive pacing rate based on thedegree of pacing.
 9. The system of claim 8 wherein the means fordetermining a degree of pacing comprises means for comparing a number ofpaced beats and a number of unpaced beats occurring during a period ofoverdrive pacing.
 10. The system of claim 9 wherein the means forcomparing comprises determining a percentage of paced beats out of atotal number of paced beats and unpaced beats.
 11. The system of claim 8wherein the means for varying the selected rate comprises means forcomparing a degree of pacing with a target degree of pacing, and meansfor adjusting the selected rate to reduce a difference, if any, betweenthe degree of pacing and the target degree of pacing.
 12. The system ofclaim 8 wherein the means for setting the overdrive pacing ratecomprises means for determining an intrinsic rate and means forcomputing an overdrive pacing rate based on the intrinsic rate.
 13. Asystem for controlling overdrive pacing of a heart, the systemcomprising: a controller that is operative to determine an overdrivepacing rate; a pulse generator that is controlled by the controller togenerate overdrive pacing pulses at the overdrive pacing rate fordelivery to the heart; a determination unit that is operative todetermine a degree of pacing resulting from the overdrive pacing pulses;and wherein the controller is coupled to the determination unit and isoperative to vary the overdrive pacing rate based on the degree ofpacing.
 14. The system of claim 13 wherein the determination unit isoperative to compare a number of paced beats and a number of unpacedbeats occurring during a period of overdrive pacing.
 15. The system ofclaim 14 wherein the determination unit is operative to determine apercentage of paced beats out of a total number of paced beats andunpaced beats.
 16. The system of claim 13 wherein the controller isoperative to compare a degree of pacing with a target degree of pacing,and is operative to adjust the overdrive pacing rate to reduce adifference, if any, between the degree of pacing and the target degreeof pacing.
 17. The system of claim 13 wherein the controller isoperative to determine an intrinsic rate and to compute an overdrivepacing rate based on the intrinsic rate.